Colon Patch

1. © Copyright Lean LaunchPad Singapore. All Rights Reserved. A Surgical Sealant for Anastomosis LeakageAjith Isaac David Ng Ee Bin Liew Gary Ang Samarth Bhargava Shawn Xiang Gao Ridzuan Farouk* *Principle Investigator

3. © Copyright Lean LaunchPad Singapore. All Rights Reserved. -Reduce risk of anasto motic Leakage -Improve healing rate -Lower Risk of re-surge ry -Ease-of-use, versatile Surgeons Patients Nurses face-to-face meetings academic conference stalls road show demos Publications and conference posters Technical assistance Generating Clinical data -SOPs for synthesis of adhesives and additives (antibiotics, healing factors) -Animal experiments, clinical trials -Regulatory approvals -Clinical adoptability -IP -materials science exp -Bioengineers Universities Hospital Colorectal Department Suture/Staple manufacturers Nurses -Sale of product -technology license and product license -Government subsidy Animal testing and clinical trials Cost for making the delivery medical device Clinican training Chemical Pre-cursors Labor Cost Initial Business Assumptions 3

4. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Key Interviewees Clinicians • Ridzuan Farouk, Dept. of Colorectal Surgery, NUH • Alfredo Franco, General Surgery, NUH • Clement Chia, General Surgery, KTP Hospital • Wu Qiang, Shenyang Chest Hospital • Dr. Yang, China Medical University Hospital • Lawarence Ho Khek Yu, NUH • Sharon Koh ZL, NUH Scientists • Chooi Kum Fai, Preclinical Research & Drug Dev.,TP • Zhang Pengchi, Biotechnology, TP • Patel Kadamb, Biosensors, TP • TAN ENG LEE, Biomedial Center, SP • Pastorin Giorgia, Dept. of Pharmacy, NUS HCPs • Ma Yuntao XNY Medical, Medical Disposables & equipments • Sales Rep, KXBD, Stapler Manufacturer • Joyce Wang, Alton, Medical Equipments • Jina Ha, BNR Endoscopic Surgical Instruments • Former New Zealand Health Ministry Official • Ding Ding, Changi General Hospital, Nurse 4 Colorectal Cancer Patients 4

5. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Overview of Interviews Customer segments Very interested Nice to have Not interested Surgeons / Doctors Total=15 5 (Colorectal) 10 (General) - Patients Total=4 - 3 1 HCPs Total=20 2 14 4 NUMBER OF INTERVIEWS: 39 5

6. © Copyright Lean LaunchPad Singapore. All Rights Reserved. -Reduce risk of anasto motic Leakage -Improve healing rate -Lower Risk of re-surge ry -Ease-of-use, versatile Surgeons Patients Nurses KOL/MSL/Distributors Surgeons Direct Sales Publications and conference posters Technical assistance Generating Clinical data -SOPs for synthesis of adhesives and additives (antibiotics, healing factors) -Animal experiments, clinical trials -Regulatory approvals -Clinical adoptability -IP -materials science exp -Bioengineers Universities/Polytech nics Hospital Colorectal Department Suture/Staple manufacturers Nurses -Sale of product -technology license and product license -Government subsidy Animal testing and clinical trials Cost for making the delivery medical device Clinican training Chemical Pre-cursors Labor Cost After 10 weeks… 6

7. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Key Learning Points • Surgical adoptability is THE key factor • No MVP for our device, the product has to be effective and safe from the beginning • R&D of Medtech product takes >3 years • We have a well-defined market segment 7

8. © Copyright Lean LaunchPad Singapore. All Rights Reserved. AHA! Moments • >100 companies manufacture ‘copycat’ medical devices in the surgical stapler sector alone • Globally, 2-3 groups are working on the same problem (AL) • AL is indeed an unmet medical need • Stapler companies are stuck with legacy products = limited innovation 8

9. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Institutes / Academia • Chemistry Innovation • Research and Development • Provide animal platform for preclinical testing • Train Students and Technicians A safe and effective surgical product Hospital • Full support from Dept. of Colorectal Surgery • Patient samples and grant application support Key Partners Build collaboration framework 9

10. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Our endpoint users What they said.. Surgeons VP: Effective, Safe, Fast, Adoptable • AL happens erratically and no current solution • Has to be bio-degradable; abscess should no form post-application Patients VP: Effective, reimbursable • Stoma bag interferes with daily life and reduces Quality of Life HCPs VP: Sustainable • Should consider sustainable development (other revenue streams) Customer Segments 10

11. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Competitor Analysis 11 Speedandeaseofuse Effectiveness * $= cost per unit Circular Staplers All Sutures *Grey out, not available in the market $$$ $

12. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Competitor Analysis(+Colon Patch) 12 Speedandeaseofuse Effectiveness * $= cost per unit Circular Staplers All Sutures *Grey out, not available in the market $$$ $ + +

13. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Market Opportunity • Average cost per Colorectal Surgery: US$ 25,000 • Number of Surgeries a year: 1.1 million • Colon Patch is to be used as a prophylactic in every surgery 13

14. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Next Steps Human Trials (Mar 2020) Regulatory approvals (Nov 2020) Marketing (Dec 2020) Proof of Value Funding: PoV Grant, ONEstart OBR, Tech Incubator Scheme Market Efficacy Pilot Study (Nov 2019) Proof of Concept Funding: Practicum Grant, PoC Grant; SMART Improving Synthesis & Adhesion (Nov 2017) Animal Efficacy Studies (Jul 2018) Delivery system (Nov 2017) Patents (Nov 2018) • Raising SGD 500k to complete the Proof of Concept stage at 30k burn pm 14

15. © Copyright Lean LaunchPad Singapore. All Rights Reserved. Team Shawn Gao PhD - NUS Medicine Ajith Amrithraj PhD - NUS Medicine Dr Ridzuan Farouk Senior Colorectal Surgeon Ee Bin Liew Industry Mentor • Dr Gary Ang, Epidemologist, NHG • David Ng, Biomed Engineer • Dr John Kuang, Materials Scientist, IMRE, A*Star • Dr Hongye, Materials Scientist, IMRE, A*Star • Andriana Justine, Industrial Design, NUS • Samarth Bhargava, PhD Chemistry, NUS Potential Collaborators: • Dr Giorgia Pastorin, Pharmacy, NUS • Animal Facility, Temasek Polytechnic • Biomedical Research Centre, Singapore Polytechnic 15